The invention relates to medicine, specifically to medical technology and can be used for electrical stimulation of organs of gastro-intestinal tract (GIT) and mucous membranes in abdominal surgery and for treatment of therapeutic type diseases.
There is known in the art an apparatus with biocontrol, used in experimental researches (see M. A. Sobakin and V. A. Shepelev xe2x80x9cFurther instrumental-methodical electrical stomach stimulation providing with use of a feedback principlexe2x80x9d, /Experimental surgery and anesthesiology/xe2x80x941973, vol. 2, p26), wherein pulses were sent at each positive phase of a patient""s own biopotential, as received from implanted electrodes. A disadvantage of the described method of electrical GIT stimulation is the restriction of its sphere of application, which is possible only [at operated sick person] with a surgery patient, and this person must be connected to the equipment.
There is known an electrical stimulator EGS-35-1 xe2x80x9cENDOTON-1xe2x80x9d, it has dimensions of 395xc3x97305xc3x97100 mm and a weight of 3 kgs (see xe2x80x9cElectrical gastro-intestinal tract stimulationxe2x80x9d, Moscow, xe2x80x9cMedicinexe2x80x9d, 1978, A. A. Vishnevsky, A. V. Livshitz, M. P. Vilyansky). In this book the modern principles and techniques of electrical GIT organs stimulation are described. This and other external electrical GIT stimulators use a set of electrodes, one of which is a rectal or duodenal probe-electrode, other is a cutaneous one, or one bipolar electrode. A disadvantage of this kind of electrical stimulator is that the patient during a session of electrical stimulation is bound to electrical stimulator by wires, therefore, the application of electrical stimulators of that kind outside of medical establishment is difficult.
There is also known a probe-stimulator for prolonged influence on a stomach and sections of GIT within the reach of a length of connecting drain (patent RU No. 1223922, MKI A61 N 1/36, published Bulletin of Inventions of Russia (BIR) No. 14, 1986). Its disadvantage is a limited sphere of application, in that only out-patient and clinical application is possible.
There is also known an electrical stimulator containing a pulse generator, power source, electrodes, and an electrode-anode entirely covered by a conductive film of microelements with thickness no less than 10 microns (patent RU No. 2036671, MKI 61 N 1/36, published BIR No. 16, 1995). A disadvantage of this invention is that the microelements from the film run within the whole length of GIT, nor does it provide enough selectivity in treatment, or feedback between a GIT condition and the subjective sensations of a patient. This restricts the application of the electrical stimulator. On the other hand, it would be advantageous if produced models of electrical stimulators typically did not rely on such films, that complicates their application.
The most close in technical essence to the offered invention is an electrical GIT stimulator containing electrodes, and having two electrical isolated parts of a medicinal capsule, where the pulse generator and power source are placed, and which capsule is capable of moving autonomously the full length of the gastro-intestinal tract, and to influence by electrical pulses the whole length of the GIT (patent RU No. 936931 MKI A61 N 1/36, published BIR No. 23, 1982). Autonomous electrical GIT stimulator can accomplish a positive effect in treatment and prophylaxis of various diseases (see xe2x80x9cAutonomous electrical stimulators of an organism of human and animalsxe2x80x9d Pekarsky V. V. and other, Siberian Medical University (SMU), Tomsk 1995, xe2x80x9cAutonomous electrical GIT stimulationxe2x80x9d Dambaev G. C. and other, Siberian gastroenterology and gepatology magazine, October 1996, V 1, No. 2). However, because of the lack of a feedback mechanism to control the operational or electrical stimulation parameters of the device in response to a condition in GIT organs relative to the subjective sensations of a patient (e.g., pains and muscular convulsions arising at passage of the device through some sections of GIT) and the limited parameters of electrical stimulation of GIT, there are a number of side-effects which contra-indicate use of the ""931 device.
The object and main problem, solved by the offered invention, is an improved autonomous electrical GIT stimulator, for treatment and prevention of certain gastro-intestinal diseases. Another object is the autonomous electrical GIT stimulator having a feedback mechanism to control the operational or electrical stimulation parameters of the device in response to the subjective sensations of a patient regarding the condition of his/her internal organs. The incorporation of a feedback element provides for control of the electrical stimulator and an opportunity to change parameters of pulses according to a method of treatment, or to the subjective sensations of a patient during use of the GIT stimulator device. This is to say that the feedback element is provided as a mechanism to control the stimulator device from outside the patient""s body, and to change the pulse parameters emitted by the device according to a specific treatment regimen, according to the subjective sensations of a patient his or herself, when trained in use of the GIT stimulator device. It is also an optional feature of the offered invention to increase the efficiency of a treatment regimen by the controlled release of prescribed microelements or preparations (drugs) from the stimulator device by an electrochemical means as it passes through the appropriate sections of the GIT. To increase the convenience of such use of the device replaceable electrodes with coatings of prescribed microelements or medicinal preparations can be installed on the device by the patient.
Another object of the electrical GIT is a receiver device and a control unit. The receiver device receives signals from internal organs (of the GIT) and/or an external transmitter. The outputs (1 to N) of the receiver device are connected to the inputs of the control unit. The control unit, based on a hardware or a program algorithm, sends a series of pulses to the M-electrodes of the electrical stimulator, depending on the signals (from the internal organs and/or the external transmitter) coming in from the receiver device.
Another object of the offered invention is a feedback mechanism the subjective sensations of the patient and the parameters of electrical stimulation of the GIT organs. The feedback mechanism is accomplished by adding sensors of signals to the receiver device. Signal sensors are for receiving signals from an external transmitter, from the internal GIT organs or from both. Feedback between the GIT organs and the stimulator of the physiological parameters of the GIT organs is used to adjust or correct the parameters of electrical pulses from the stimulator depending on the changes in the physiological parameters of the GIT. The receiver device may contain sensors for: pressure, a gradient (difference) of pressure, pH, acoustics, temperature, biopotential, and conductivity of stimulated tissue. Therefore, the present stimulator may adjust its output pulse parameters in response to feedback received from the sensors or by way of an external signal transmitted, for example, by the patient in response to subjective sensation.
To further increase treatment efficiency, the offered invention includes the installation of additional P-electrodes of selected microelements or medical preparations as required, into a section of the GIT stimulator. The additional P-electrodes have a coating of microelements or medicinal preparations, and are connected to the separate outputs of the control unit. In keeping with the purpose of improved treatment and prevention, and for convenience of use, replaceable P-electrodes are used in the offered electrical GIT stimulator. The additional P-electrodes can be carried out as demountable or replaceable by a user of the device.
The offered electrical GIT stimulator, comprises a casing in the form of a medicinal capsule and having surface electrodes. The casing containing a power source, a control unit, outputs connected to M-electrodes, a receiving device having outputs connected to inputs of a control unit, and a control unit. The dimensions and the shape or form of electrical stimulator are limited by the requirement of its introduction into gastro-intestinal tract orally or rectally, or of its vaginal use.
The receiver device receives signals from the internal GIT organs, an external transmitter or from both. The receiver device comprises sensors for sensing physiological parameters of motor evacuative function and current condition of GIT organs, and also signals from an external transmitter, the outputs of which being inputs of the receiver device. The sensors of the receiver device for receiving signals from internal GIT organs include: a sensor of pressure, a sensor of pressure gradient, a pH-sensor, an acoustic sensor, a sensor of temperature, a sensor of biopotential, a sensor of conductivity. Alternatively, the electrodes of the electrical stimulator can be used as the electrodes of the sensor of biopotential and of the sensor of conductivity.
The offered electrical stimulator in addition contains a signal transmitter having inputs which are connected to the outputs of the receiver device, and to a separate output of the control unit.
The control unit in the best embodiment contains a micro-controller. The micro-controller has analog-digital amplifier circuits the inputs of which are connected from the receiving device through the amplifiers to the outputs of the micro-controller device, its outputs being the M outputs of the control unit. Accordingly, the outputs of the control unit are connected to the M-electrodes of electrical stimulator. Likewise, the additional outputs of the micro-controller, being the outputs of the control unit, are connected to the additional P-electrodes.
The main positive effect, which autonomous electrical GIT stimulators have is their ability to restore the motor-evacuative function of the GIT. The offered electrical GIT stimulator, in contrast to what is known, is capable not only to move autonomously through the gastro-intestinal tract, but also to selectively influence GIT sites by intermittently applying electrical pulses to the sites, consecutively restoring functions of organs along the whole length of the GIT. Along with the positive effect of autonomous electrical stimulation of the offered stimulator on GIT organs already proved experimentally and in a wide clinical practice, the application of the offered electrical stimulator gives a new opportunity to selectively and purposefully influence by electrical stimulation specific sections and organs of GIT. This new opportunity to increase treatment efficiency is owing to the ability to introduce prescribed medicinal preparations and microelements to the necessary GIT sections by an electrochemical way or means. The opportunity to adjust the pulse parameters of the autonomous electrical stimulator depends on a condition of internal organs appearing as a subjective sensation of a patient. Also, the opportunity to select modes of autonomous electrical stimulation depends on the character of a disease and from a current condition of GIT motor activity, and from other parameters indicative of a condition of GIT organs detected by the sensors.
The above named purposes, characteristics and advantages of the present invention will be more clear from the following detailed description, which is accompanied by the appropriate drawings.